Clinical trial · Interventional
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
NCT00090220CI-TRIAL-00027113completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Adult Female Participants | — | UNRESOLVED | — |
| Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 | — | UNRESOLVED | — |
| Papillomavirus Infection | — | UNRESOLVED | — |
| Prevention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Placebo | Biological | — | UNRESOLVED |
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- qHPV Vaccine in Base Study
- description
- Participants received blinded qHPV vaccination at Day 1, Month 2, and Month 6 of the Base Study
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- type
- PLACEBO_COMPARATOR
- label
- Placebo in Base Study
- description
- Participants received blinded placebo at Day 1, Month 2, and Month 6 in the Base Study. They were eligible to receive open-label qHPV vaccine in Extension 1
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Biological: Comparator: Placebo
Primary outcomes (26)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 24 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) * Not pregnant and agrees to use effective contraception through Month 7 of the study * Additional criteria applied Exclusion Criteria: * Pregnant * Concurrently enrolled in a clinical study involving collection of cervical specimens * Previously received any HPV vaccine * History of severe allergic reaction that required medical intervention * Received any immune globulin or blood-derived products within 3 months prior to the first study injection * History of splenectomy, known immune disorders, or receiving immunosuppressives * Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection * Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections * History of recent or ongoing alcohol or drug abuse * Prior treatment for genital warts, VIN, or VaIN * History of cervical disease (ie, surgical treatment for cervical lesions) * Hysterectomy
References
Publications (8)
- RESULTMunoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. doi: 10.1016/S0140-6736(09)60691-7. Epub 2009 Jun 1. PMID 19493565
- RESULTVelicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and incidence of HPV genital infection in women. Sex Transm Dis. 2009 Nov;36(11):696-703. doi: 10.1097/OLQ.0b013e3181ad25ff. PMID 19652630
- RESULTCastellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31. PMID 21629249
- RESULTLuna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, Radley D, Vuocolo S, Haupt RM, Saah A. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013 Dec 31;8(12):e83431. doi: 10.1371/journal.pone.0083431. eCollection 2013. PMID 24391768
- RESULTMatys K, Mallary S, Bautista O, Vuocolo S, Manalastas R, Pitisuttithum P, Saah A. Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. Clin Vaccine Immunol. 2012 Jun;19(6):881-5. doi: 10.1128/CVI.00002-12. Epub 2012 Apr 18. PMID 22518014
- RESULTGarland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.